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Otology Suction Tubes - HSA Registration DE0016305

Access comprehensive regulatory information for Otology Suction Tubes in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016305 and owned by Integra LifeSciences Corporation. The device was registered on September 09, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0016305
Otology Suction Tubes
HSA Registration Number: DE0016305
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Product Description

Manual surgical instruments are intended for use in a wide variety of surgical procedures including otorhinolaryngology, head and neck, otoneurological, ophthalmic, coelioscopic and laparoscopic surgeries. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures. They include instrument trays and suction devices designed to evacuate gas, fluid, tissue or other foreign materials. It is the responsibility of the surgical team to select the appropriate instrument for each case.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0016305
Registration Date
September 09, 2014
Change Notification Approval Date
August 05, 2016
Retention Due Date
September 08, 2025
Product Owner
Short Name
Integra LifeSciences
Address
311 Enterprise Drive, Plainsboro, NJ 08536, UNITED STATES
Registrant
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model Information
Model Name(s)
SUCTION HANDLE WITH FINGER CONTROL 1/EA ANG UCTION TUBE,LUER LOCK,8.5CM,0.5MM ANG SUCTION TUBE,LUER LOCK,8.5CM,0.7MM ANG SUCTION TUBE,LUER LOCK,8.5CM,1MM ANG SUCTION TUBE,LUER LOCK,8.5CM,1.2MM ANGLED SUCTION TUBE,LUER LOCK,1.5MM DIA. ANGLED SUCTION TUBE,LUER LOCK,1.8MM DIA. ANGLED SUCTION TUBE,LUER LOCK,2.0MM DIA. ANGLED SUCTION TUBE,LUER LOCK,2.4MM DIA. OLIVE SHAPED CONN. SUCTION TUBE,1MM OLIVE SHAPED CONNECT SUCTION TUBE, 1.2MM OLIVE SHAPED CONNECT SUCTION TUBE, 1.5MM OLIVE SHAPED CONNECT SUCTION TUBE, 1.8MM OLIVE SHAPED CONNECT SUCTION TUBE, 2 MM OLIVE SHAPED CONN. SUCTION TUBE,2.5MM OLIVE SHAPED CONN. SUCTION TUBE,3MM OLIVE SHPD CNNECTN SUCTN TUBE 3.5,1/EA OLIVE SHPD CNECTN SUCTN TUBE 4.0,1/EA BRACKMANN SUCTION IRRIG. TUBE,2MM 1/EA BRACKMANN SUCTION IRRIG. TUBE,2.5MM 1/EA BRACKMANN SUCTION IRRIG. TUBE,3MM 1/EA WERTHEIMER SUCTION TUBE,1.5MM 1/EA WERTHEIMER SUCTION TUBE, 2 MM 1/EA WERTHEIMER SUCTION TUBE, 2.5 MM 1/EA WERTHEIMER SUCTION TUBE, 3 MM 1/EA WERTHEIMER SUCTION TUBE, 3.5 MM 1/EA WERTHEIMER SUCTION TUBE, 4 MM 1/EA SUCTION HANDLE WITH FINGER CONTROL 1/EA
Model Identifier(s)
MCO1 MCO3-0-5 MCO3-0-7 MCO3-1-0 MCO3-1-2 MCO3-1-5 MCO3-1-8 MCO3-2-0 MCO3-2-4 MCO311-1-0 MCO311-1-2 MCO311-1-5 MCO311-1-8 MCO311-2-0 MCO311-2-5 MCO311-3-0 MCO311-3-5 MCO311-4-0 MCO352-20 MCO352-25 MCO352-30 MCO770-1-5 MCO770-2-0 MCO770-2-5 MCO770-3-0 MCO770-3-5 MCO770-4-0 MCO776